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FDA 510(k)

Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)

K-Number: K170670 · 2017-05-31

ApplicantbioMerieux, Inc.
Decision Date2017-05-31
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K170670. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)?

Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is bioMerieux, Inc.. The 510(k) number is K170670.

When did Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) receive FDA 510(k) clearance?

Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) received FDA 510(k) clearance on 2017-05-31, under 510(k) number K170670.

Who is the listed applicant for Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)?

The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)?

The FDA product code for Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) is JWY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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